NCT01436799

Brief Summary

The investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 26, 2013

Completed
Last Updated

September 9, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

September 15, 2011

Results QC Date

February 5, 2013

Last Update Submit

August 25, 2013

Conditions

Keywords

propofoldesfluranecerebrovascular circulationsitting

Outcome Measures

Primary Outcomes (1)

  • Regional Cerebral Oxygen Satuation (rSO2)

    definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)

    1, 3, 5, 7, and 9 min after the beach chair position

Study Arms (2)

Desflurane

EXPERIMENTAL

anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane

Drug: DesfluraneDrug: alfentanilDrug: Rocuronium

propofol

ACTIVE COMPARATOR

anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model

Drug: propofolDrug: alfentanilDrug: Rocuronium

Interventions

anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly.

propofol

anaesthesia was maintained by desflurane 4-7vol%

Also known as: Des
Desflurane

administration of alfentanil 10 μg kg-1 for anesthetic induction

Also known as: alf
Desfluranepropofol

administration of rocuronium 0.6 mg kg-1 for anesthetic induction

Also known as: roc
Desfluranepropofol

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Forty patients,
  • ASA class I or II,
  • undergoing shoulder arthroscopy

You may not qualify if:

  • Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index \> 30) were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Ischemia

Interventions

PropofolDesfluraneDesminAlfentanilGTF2A1L protein, humanRocuroniumROC Curve

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedIntermediate Filament ProteinsBiopolymersPolymersMacromolecular SubstancesCytoskeletal ProteinsProteinsAmino Acids, Peptides, and ProteinsFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSensitivity and SpecificityEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesStatistics as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Limitations and Caveats

limitations of this study is that the ventilation was adjusted according to ETCO2 value instead of the arterial carbon dioxide tensions (PaCO2).

Results Point of Contact

Title
Dr.HJ Kwak
Organization
Gachon University Gil Medical Center

Study Officials

  • Hyun Jeong Kwak, MD.PhD

    Gachon University Gil Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 20, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 9, 2013

Results First Posted

August 26, 2013

Record last verified: 2013-08